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A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)

NCT07013487 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12000

Last updated 2026-05-12

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that V181 is safe and well tolerated, elicits an immune response, and reduces the frequency of virologically confirmed dengue (VCD) of any severity, due to any of the 4 dengue serotypes, regardless of dengue serostatus at baseline in children 2 to 17 years of age.

Conditions

  • Healthy

Interventions

BIOLOGICAL

V181

Participants will receive a single 0.5 mL SC dose of V181 on Day 1.

BIOLOGICAL

Placebo

Participants will receive a single 0.5 mL SC dose of placebo on Day 1.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2031-10-24
Completion
2031-10-24
FDA Drug
Yes

Countries

  • Indonesia
  • Malaysia
  • Philippines
  • Puerto Rico
  • Singapore
  • Thailand
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07013487 on ClinicalTrials.gov